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Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01272414
First received: January 6, 2011
Last updated: September 14, 2011
Last verified: December 2010
History of Changes
  Purpose

Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.


Condition Intervention Phase
Graves Ophthalmopathy
 Drug: Botulinum Toxin Type A
Drug: Saline injection
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Reduction in upper lid retraction (in mm) [ Time Frame: 4 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective improvement in lid retraction related dry eye symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    ocular surface disease index score

  • Subjective improvement in lid retraction related cosmesis [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Graves Orbitopathy quality of life score


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BoTox Treatment
Subjects receive BoTox injection to levator complex
 Drug: Botulinum Toxin Type A
2-12 units in weekly 2u doses to effect
Other Name: BoTox
Placebo Comparator: Saline injection
Saline injection to levator complex
 Drug: Saline injection
Injection of 0.4cc 0.9% normal saline
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months.
  • Upper eyelid retraction of 1mm or greater.
  • Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

  • Less than 18 years of age
  • Age over 65 years
  • Pregnant or nursing
  • Known peripheral neuropathy or neuromuscular junction disorder
  • Demonstrated allergy to BoTox
  • Current infection over the injection site
  • Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers.
  • Previous or concurrent prednisone therapy
  • Undergone previous upper eyelid surgery
  • Severe vision threatening TO
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272414

Contacts
Contact: Nancy Tucker, MD FRCSC (416) 586-4800 ext 6757 nancytucker@me.com
Contact: Daniel B Rootman, MSc MD (416) 586-4800 ext 6757 dan.rootman@gmail.com

Locations
Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Nancy Tucker, MD FRCSC     (416) 586-4800 ext 6757     nancy.tucker@mac.com    
Principal Investigator: Nancy Tucker, MD FRCSC            
Sub-Investigator: Daniel B Rootman, MSc MD            
Sub-Investigator: Jeffrey J Hurwitz, MD FRCSC            
Sub-Investigator: Dan DeAngelis, MD FRCSC            
Sponsors and Collaborators
University of Toronto
Allergan
Investigators
Principal Investigator: Daniel B Rootman, MSc MD University of Toronto
Principal Investigator: Nancy Tucker, MD FRCSC University of Toronto
  More Information

No publications provided

Responsible Party: Dr Nancy Tucker, MD FRCSC, University of Toronto
ClinicalTrials.gov Identifier: NCT01272414     History of Changes
Other Study ID Numbers: 10-0261-A
Study First Received: January 6, 2011
Last Updated: September 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Toronto:
Eyelid retraction
Botulinum Toxins

Additional relevant MeSH terms:
Hyperthyroidism
Eye Diseases
Graves Ophthalmopathy
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013